Actively Recruiting
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics in Peripheral Arterial and Venous Disease
Led by MIMOSA Diagnostics Inc. · Updated on 2025-09-11
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
MIMOSA Diagnostics Inc.
Lead Sponsor
N
Northwell Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether tissue oxygenation measurements obtained from the MIMOSA Pro multispectral near-infrared imaging device correspond to standard vascular assessment tools used in patients undergoing lower extremity vascular evaluations. It focuses on patients with peripheral vascular disease and chronic wounds of the lower limb. The study will explore correlations between MIMOSA Pro measures and clinical tests like the ankle-brachial index, toe-brachial index, transcutaneous oximetry, and Doppler waveforms, and how these relate to disease classifications and wound stages. Participants will continue with their usual vascular assessments including ankle-brachial index exams and other standard tests. They will also have additional imaging of their legs using the MIMOSA Pro device, which is non-interventional and used as an adjunct tool in the wound center. The study does not use MIMOSA device data to make clinical decisions. Participants will be followed for about two months during their regular visits. Throughout the study, investigators will assess participants' vascular and wound status while collecting standard diagnostic data and MIMOSA Pro imaging results. The primary outcome is the correlation between MIMOSA oxygenation measures and standard vascular tools from baseline to the end of study. Secondary outcomes include correlation between MIMOSA measures and disease or wound severity. The study aims to understand the potential clinical utility of MIMOSA Pro imaging during standard care and involves no additional treatments or interventions beyond imaging and assessments.
CONDITIONS
Brief Title
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female, aged 18 years and older
- Undergoing an ankle-brachial index (ABI) test
- Recently had or will have further vascular assessments such as transcutaneous oxygen pressure and Doppler waveforms as part of standard care
- Able to be followed by the same investigating team throughout the study period
You will not qualify if you...
- Currently participating in another clinical study for ulcer management
- Unable to understand the study aims or provide informed consent
- Receiving radiation to the extremity
- Active Charcot joints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo standard vascular assessments including ankle-brachial index, transcutaneous oxygen pressure, and Doppler waveforms as part of routine care. Additional imaging of the lower extremities using multispectral near-infrared (MS-NIR) imaging is performed as an adjunct tool.
1 baseline visit (in-person)
Duration - 2 months
Participants are followed for 2 months with regularly scheduled visits to monitor disease and wound status, correlating standard vascular assessment results with MS-NIR imaging measures.
Regularly scheduled visits during the 2-month follow-up period
Trial Site Locations
Total: 1 location
1
Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
A
Alisha Oropallo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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